HRV Pharma - Market Expansion Leader in Pharmaceuticals.

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01 1HRV Pharma
02 2Nuray Chemicals Private Limited
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1ChemExpress
05 1ApiSyn
06 1Dasami Lab
07 1Emnar Pharma
08 1MSN Laboratories
09 1Procos
10 1Shodhana Laboratories
11 1Virchow Group
12 1Viyash Life Sciences
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01 1China
02 11India
03 1Italy
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01 1WC-0230
02 1WC-0416
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01 114501-0114
02 146016-9030
03 158159-084
04 158159-092
05 170966-0038
06 171901-614
07 173435-034
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39721
Submission : 2024-04-01
Status : Active
Type : II
| Available Reg Filing : AU |
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-31
Pay. Date : 2023-03-15
DMF Number : 36859
Submission : 2022-03-01
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-092
Start Marketing Date : 2022-09-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-07-28
Pay. Date : 2023-07-06
DMF Number : 37753
Submission : 2022-12-31
Status : Active
Type : II
NDC Package Code : 73435-034
Start Marketing Date : 2023-12-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-19
Pay. Date : 2023-03-21
DMF Number : 38174
Submission : 2023-03-30
Status : Active
Type : II
NDC Package Code : 58159-084
Start Marketing Date : 2021-06-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-22
Pay. Date : 2024-07-25
DMF Number : 39126
Submission : 2023-12-05
Status : Active
Type : II
NDC Package Code : 71901-614
Start Marketing Date : 2025-03-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-22
Pay. Date : 2023-04-21
DMF Number : 38307
Submission : 2023-05-09
Status : Active
Type : II
NDC Package Code : 70966-0038
Start Marketing Date : 2019-08-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT



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PharmaCompass offers a list of Pitolisant Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pitolisant Hydrochloride manufacturer or Pitolisant Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pitolisant Hydrochloride manufacturer or Pitolisant Hydrochloride supplier.
A Pitolisant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pitolisant, including repackagers and relabelers. The FDA regulates Pitolisant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pitolisant API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Pitolisant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pitolisant supplier is an individual or a company that provides Pitolisant active pharmaceutical ingredient (API) or Pitolisant finished formulations upon request. The Pitolisant suppliers may include Pitolisant API manufacturers, exporters, distributors and traders.
click here to find a list of Pitolisant suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 12 companies offering Pitolisant
Get in contact with the supplier of your choice: